David Schwartz: On Thursday, June 13th, 2013, the Supreme Court issued a patent decision that has profound implications for the US biotechnology industry. In Association for Molecular Pathology versus Myriad Genetics, a unanimous Supreme Court held that isolated DNA was not eligible for patents while, in the same opinion, the Supreme Court ruled that CDNA was eligible for patents provided that the other requirements of patentability, namely that the invention was new, non-obvious and useful, were satisfied.
So, at issue in the case were several patents held by Myriad Genetics. Myriad discovered the precise location and sequence of the BRCA1 and BRCA2 genes. A mutation in those genes indicates that a woman is at heightened predisposition to breast and ovarian cancer.
Myriad had obtained a number of patents at—on that discovery. Some of the patents dealt with isolated DNA, and so that's DNA that had been extracted from the body using well known techniques. Myriad also obtained patents on CDNA or complimentary DNA, which is lab generated DNA. The patents gave Myriad the ability to exclude others from isolating the BRCA1 and 2 genes.
The Federal Circuit Court of Appeals, the lower court that hears all patent appeals, had affirmed the patentability of both the isolated DNA and the CDNA. And so, Justice Thomas writing for a unanimous Supreme Court held that the isolated DNA claims were not patent eligible.
Justice Thomas first explained that the patent laws provided a delicate balance between, on the one hand, encouraging innovation, and on the other hand, making sure that the basic building blocks and tools of scientists were not held by a few that would impede innovation.
And to kind of strike this balance, the court used the doctrine of patent eligibility, and Justice Thomas noted that the Supreme Court has held that there are three things that are excluded from patent eligibility historically - laws of nature, abstract ideas and natural phenomenon.
And here, when Justice Thomas looked at the isolated DNA, he said that that was—he for the court said that that was the same as what existed in nature and the fact that Myriad Genetics had spent a lot of money and a lot of time developing it or finding the genes did not render the genes patent eligible. Justice Thomas also said that the Patent Office's longstanding practice of allowing patents on isolated DNA did not save the day and that, therefore, the claims that Myriad had unisolated DNA were not patent eligible.
In a relatively brief section on the CDNA claims, Justice Thomas said that those were eligible for patents because those were created by a lab technician and those were not existing in nature.
So, while the precise implications of the decisions are not yet apparent, one thing is apparent—several companies in the several days after the opinion was announced have already publicly stated that they will offer testing for patients on the BRCA1 and 2 genes, and they will do so at a price that's lower than what Myriad Genetics had previously offered.
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